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The rare transplant patients who quit Anti-Rejection drugs: can a blood test find others like them?

NCT ID NCT01516177

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are studying people who received a kidney transplant one to five years earlier. The goal is to find out how common a certain pattern of genes and immune cells in the blood is among transplant recipients. That pattern was first spotted in a small number of patients who no longer need anti-rejection drugs. The study measures blood samples over time to see whether the pattern appears, changes, or stays stable, as a first step toward personalizing immunosuppression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers can reliably spot this pattern, doctors may one day use a blood test to tailor anti-rejection drug doses for kidney transplant patients, sparing some from unnecessary medication.
What could go wrong
This is an observational study, so it cannot prove the pattern predicts anything on its own. The signature was first seen in a small group of unusual patients, and it may turn out to be rare, unstable over time, or not useful for guiding treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

250 people

The number who actually took part.

Start date

Sep 2010

Finished

Apr 2014

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria. Among those eligible for further follow-up * at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and * at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Received first kidney transplant from a living or deceased donor. * Kidney transplanted between 1 and 5 years ago. * Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months * Ability to understand and provide informed consent. Exclusion Criteria: * History of steroid-resistant acute rejection * History of two or more episodes of acute rejection * Any acute rejection in the past year * Current malignancy * Transplant of another organ * AIDS according to the CDC definition of AIDS.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplantation

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

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